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Combs TR, Scott J, Jorski A, Heavener T, Vassar M. Evaluation of Industry Relationships Among Authors of Clinical Practice Guidelines in Gastroenterology. JAMA Intern Med. 2018;178(12):1711–1712. doi:10.1001/jamainternmed.2018.4730
Financial conflicts of interest (FCOI) may unduly influence physician decision-making. For this reason, the Institute of Medicine recommends that guideline development teams be composed of at most 50% authors who have financial relationships to disclose, and recommends abstaining from financial conflicts for a period of 1 year following guideline publication.1 Several studies have evaluated the extent of FCOI between industry and authors of clinical practice guidelines (CPGs) in dermatology,2 oncology,3 and otolaryngology4; however, such an analysis has not been performed in gastroenterology. Our objectives were to evaluate industry payments received by, and FCOI disclosure practices of, authors of 15 gastroenterology clinical practice guidelines.
We retrieved information about CPGs, including the names of authors and their disclosed FCOIs, from the American College of Gastroenterology (ACG) website.5 Individual payment data was retrieved for each guideline author using the 2014 to 2016 Centers for Medicare and Medicaid Services (CMS) OpenPayments database (OPD) (Table).6 Because the ACG does not clearly delineate a recommended conflict-free interval for its guideline authors, we assessed a period beginning 6 months prior to and ending 6 months following guideline publication, for a total of 12 months, which was the longest possible timeframe permitting analysis of the same number of months of OPD payment records for each ACG guideline published between 2014 and 2016. OpenPayments identifies 4 payment categories: general, research, associated research, and ownership. The general category includes compensation for food/beverage, travel, speaking fees, consulting fees, honoraria and other services. Transactions falling outside the prespecified date range or those categorized as food/beverage were excluded. We calculated medians and interquartile ranges (IQRs) for each guideline for both total and general payments received. We also evaluated, qualitatively, whether authors did or did not disclose any FCOI in a CPG and whether or not any evidence of potential FCOI was found on OPD. All statistical analyses were performed using Microsoft Excel (version 15.38, Microsoft).
Among the 15 CPGs identified from the ACG website, there were 83 total authors (median number of authors per CPG, 4; IQR, 3-6). Overall, 44 of 83 (53%) authors received industry payments and the median percentage of guideline authors with FCOIs per CPG was 50% (IQR, 50%-75%). The median total payments received by guideline authors was $1000 (IQR, $0-$39 938). Both the number of authors with industry relationships and the magnitude of those relationships varied greatly between guidelines (Table). Among the 83 authors, only 16 (19%) both disclosed FCOIs in the CPG and had received payments according to OPD or had disclosed no FCOIs and had received no payments according to OPD. Among 146 cumulative FCOIs disclosed by authors and 148 relationships identified on OPD, only 49 (34%) were both disclosed as FCOI and evidenced by OPD payment records.
Our investigation sought to understand and characterize the extent of relationships between authors of CPGs in gastroenterology and their efforts to disclose those relationships to relevant stakeholders. Our findings suggest that although almost half of authors have no industry relationships, those who do often receive sizable sums. Our finding that FCOI disclosure only corroborates with OPD payment records between 19% and 34% of the time also suggests that guidance from the ACG may be needed to improve FCOI disclosure efforts in future iterations of gastroenterology CPGs. One limitation of our study is that we were only able to evaluate a period of 12 months for each guideline. The ICMJE advocates for disclosure of relationships for 36 months prior to CPG authorship, so our analysis may underestimate the prevalence of industry relationships among gastroenterology CPG authors. We recommend that the ACG draft new policies with specific expectations for FCOI disclosure among authors of gastroenterology CPGs, and that large-scale efforts be made to improve the comprehensiveness and reliability of the OpenPayments Database.
Corresponding Author: Tyler R. Combs, BS, Center for Health Sciences, Oklahoma State University, 1111 W 17th St, Office A-228, Tulsa, OK 74107 (email@example.com).
Accepted for Publication: July 22, 2018.
Published Online: October 29, 2018. doi:10.1001/jamainternmed.2018.4730
Author Contributions: Dr Combs had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Combs, Scott, Vassar.
Acquisition, analysis, or interpretation of data: Combs, Jorski, Heavener.
Drafting of the manuscript: Combs, Jorski, Vassar.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: All authors.
Study supervision: Scott, Vassar.
Conflict of Interest Disclosures: None reported.
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